PMD launches first personal spirometer

ALLENTOWN, Pa. — Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.

PMD, based in Allentown, Pa., announced the launch of the Spiro PD, which recently received approval from the Food and Drug Administration. The device is designed to enable patients with such lung diseases as asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung transplants "easily and accurately" monitor lung function anytime and anywhere.

"With the increase in prevalence of emergency room visits and hospitalizations for asthma and other pulmonary problems in the U.S., the availability of Spiro PD is especially significant," World Allergy Organization board member and University of Tennessee Health Sciences Center clinical professor Michael Blaiss said. "This new device allows patients and parents of young children with lung disease to know exactly how their condition is doing at any time, enabling patients to have a more active role in controlling their lung health and potentially identifying problems before the need for costly emergency treatment."

The claims at issue were initially challenged before the National Advertising Division of the Council of Better Business Bureaus by Pfizer Consumer Healthcare, makers of Advil.

NAD determined that Novartis did not provide a reasonable basis to support those claims, the review organization stated. NARB noted in its decision that when efficacy claims are made for pain-relief medication, “those claims must be supported by at least one adequate and well-controlled scientific study that measures efficacy in treating the type of pain for which efficacy is claimed — e.g., substantiation for claims involving relief of tension headache pain should include at least one scientific study that evaluates efficacy in treating tension headache pain.”

In this case, Novartis offered as support for its claims studies related to migraine and dental pain, as well as one study — the “201 study," which evaluated speed of relief in treating tension headaches.

The panel noted that the "201 study" focused on the following “four analgesic variables” during the first hour after ingestion of the test medication:

Time to at least half relieved pain;

Time to complete pain relief;

Weighted sum of pain intensity difference scores; and

Time to meaningful pain relief.

The study found no statistically significant differences between subjects who received Excedrin and subjects who received Advil with respect to the first three variables. While a statistically significant difference of 5.1 minutes was arguably found in looking at median time to achieve meaningful pain relief within the first hour, no statistically significant differences were found at any of the 10-minute measurements except for the 40-minute measurement, NARB noted.

Novartis, in its advertiser’s statement, stated the company “disagrees with the NAD and NARB conclusions regarding the scientific substantiation in issue but will comply with the recommendations made."

Help Remedies introduces guaifenesin SKU

NEW YORK — Help Remedies last week launched a new product targeted toward those suffering from chest congestion. The new expectorant, branded "Help I have chest congestion," contains the single active ingredient guaifenesin (200 mg), and is now available nationally at Target, the company stated.

"Help I have chest congestion" becomes the eighth in Help’s line of over-the-counter healthcare products, nationally distributed through retailers, including Target, Walgreens, Duane Reade, Pharmaca, 3floz.com, regional supermarkets and boutique hotels. Each pack of "Help I have chest congestion" contains 16 tablets and has a suggested retail price of $3.99.

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